AKI, Ascorbic Acid, Contrast-induced Nephropathy, Statin
Conditions
Brief summary
To evaluate the benefit for statin use in prevention of of CI-AKI after computed tomography urogram (CTU).
Interventions
DRUGAtorvastatin-Ascorbic acid
atorvastatin (80-mg loading dose given a mean 24 hours before procedure with another 40-mg dose approximately 2 hours before the procedure and for 3 days) plus ascorbic acid 500mg
DRUGPlacebo
Placebo
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Planned computed tomography urogram (CTU) * Statin naive, or not on statin treatment for at least 14 day
Exclusion criteria
* History of liver disease or elevated serum transaminases * History of rhabdomyolysis or elevated creatinine kinase * History of iodinated CM use within 14 days before randomization * History of N-acetylcysteine, metformin or nonsteroidal anti-inflammatory drugs use within 48 hours of the procedure. * History of hypersensitivity reaction to contrast media * Pregnancy or lactation * Acute renal failure * End-stage renal disease requiring dialysis * Cardiogenic shock or pulmonary edema * Multiple myeloma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contrast Induced-Acute Kidney Injury | 3 days | Increase in serum creatinine ≥ 0.5 mg/dl or ≥ 25 % within 72 hours of contrast medium exposure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| long-term Renal function by estimated GFR | 30 days | measured in ml/min/1.73m2 |
Countries
Egypt
Outcome results
None listed